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临床试验/NCT01583348
NCT01583348已完成不适用

An Open Case Series About Technical Feasibility of Routine Intraoperative Cholangiography (IOC) During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy (tvNCC)

Cantonal Hosptal, Baselland1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)

研究概览

简要总结

While gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is feasible during such procedure. This observational case series describes success and technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy. The investigators hypothesis is that cholangiography is feasible equal to conventional laparoscopic cholecystectomy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • symptomatic gallstone disease
  • age > 18 years
  • written informed consent

排除标准

  • age < 18 years
  • not able to understand informed consent
  • pregnancy
  • vaginal atresia
  • florid vaginal infection
  • gynecological neoplasia
  • allergy to Iod
  • missing informed consents
  • emergency procedure

结局指标

主要结局

Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)

时间窗: intraoperative

Was the introduction of the cholangiography catheter into the cystic duct successfull during transvaginal rigid-hybrid cholecystectomy.

次要结局

  • Time required for cholangiography(intraoperative)
  • Intraoperative complications(intraoperative)
  • postoperative complications(within 6 weeks from surgery)

研究者

发起方
Cantonal Hosptal, Baselland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Steinemann, MD

Principle Investigator

Cantonal Hosptal, Baselland

研究点 (1)

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